Benzinga | Feb 23, 2021 08:07AM EST

RedHill Biopharma Expands Opaganib Global COVID-19 Study To US

* Following the FDA review of data from the U.S. Phase 2 study of opaganib and receipt of its recommendations, RedHill Biopharma Ltd (NASDAQ: RDHL) plans to expand its global Phase 2/3 study of opaganib in patients with severe COVID-19 to the U.S.

* The study's expansion to the U.S. will help further speed-up enrollment, expand the study to eight countries and approximately 40 recruiting sites. The 464-patient study is over 50% enrolled, and topline data expected in the second quarter of 2021.

* The global Phase 2/3 study recently underwent a positive DSMB futility review, which is suggestive that the study has the potential for a positive outcome.

* In December last year, the company announced positive topline data from the non-powered U.S. Phase 2 study with opaganib in patients with COVID-19 pneumonia and demonstrated positive safety and efficacy signals.

* Opaganib is an orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity that targets a human cell component involved in viral replication.

* Price Action: RDHL shares are down 3.0397% at $10.95 in the premarket trading on the last check Tuesday.